Journal of Clinical Trials
Open Access

Abstract

Neoadjuvant Chemoradiation for Unfavourable Breast Cancer Patients: A Prospective Cohort Study

Raquel Ciervide, Angel Montero, Mariola Garcia-Aranda, Estela Vega, Mercedes Herrero, Natalia Ramirez, Jessica Skaarup, Cristina Marquez, Manuela Parras, Cristina Pernaut, Maria Lopez, Beatriz Rojas, Lina Garcia-Canamaque, Ana Suarez, Xin Chen, Rosa Alonso, Pedro Fernandez Leton, Eva Ciruelos and Carmen Rubio

Purpose: Reaching a complete pathological response (pCR) after primary systemic treatment (PST), specifically in the subgroup of patients with triple negative (TNBC) or HER2-positive tumors, is associated with a significant survival gain. The combination of chemotherapy and radiotherapy could increase this synergistic benefit.

Methods/Design: This is an unicentric prospective cohort study that is going to include 40 localized breast cancer patients (TNBC or HER-2 positive) T2N0 or higher to receive neoadjuvant chemoradiation based on Pertuzumab-Trastuzumab-Paclitaxel followed by anthracyclines in Her-2 positive patients and CBDCA-Paclitaxel based regimen followed by anthracyclines in TNBC patients. Chemoradiotherapy concomitance will be with CBDCAPaclitaxel/ Paclitaxel-Her-2 double blockage. Dose prescribed will be 40,5 Gy in 15 fractions of 2.7 Gy, five fractions a week, to whole breast and ganglionar levels I-IV and ipsilateral internal mammary chain when indicated with simultaneous integrated boost of de 54 Gy in 15 fractions of 3.6 Gy to primary breast and/or axillary tumor (highlighted by PET). The primary study endpoint will be to asses pathological complete response rates (pCR) and objective response (OR) rates. Secondary endpoints will include to asses metabolic response rates by 18FDG-PETCT, locoregional control and disease-free survival rates, tolerance and viability and security of the surgery after preoperative chemoradiotherapy.

Discussion: Tools and results developed in this study are aimed at answering if preoperative chemoradiation improves pathological and objective response and ultimately improves survival rates, tolerance and viability of surgery in desfavorable breast cancer subtypes.